Dose escalation to intraprostatic tumour nodules in localised prostate cancer

ISRCTN	ISRCTN04483921
DOI	https://doi.org/10.1186/ISRCTN04483921
Protocol serial number	10309
Sponsor	Institute for Cancer Research (UK)
Funder	Cancer Research UK (CRUK) (UK)

Submission date: 17/08/2011
Registration date: 17/08/2011
Last edited: 29/09/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-increasing-dose-of-radiotherapy-to-areas-of-cancer-inside-prostate-gland-delineate

Contact information

Ms Annie Gao
Scientific

Downs Road
Sutton
SM2 5PT
United Kingdom

Email	annie.gao@rmh.nhs.uk

Study information

Primary study design	Interventional
Study design	Non-randomised; Interventional; Design type: Process of Care, Treatment
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Dose EscaLation to Intraprostatic tumour Nodules in localisEd prostATE cancer: A phase II study examining the toxicity and feasibility of a dose escalated boost to a magnetic resonance imaging identified tumour nodule or nodules in localised prostate cancer
Study acronym	DELINEATE
Study objectives	Dose Escalation to Intra-prostatic Tumour Nodules in Localised Prostate Cancer To assess the toxicity and feasibility of a dose escalated intensity-modulated radiotherapy boost to tumour nodules within the prostate using anatomical and functional magnetic resonance (MR) imaging to identify tumour. The aim is to maintain current levels of late toxicity.
Ethics approval(s)	11/LO/0510
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate
Intervention	Interventions as of 03/05/2017: 350 patients to be recruited and have MRI scans to diagnose intra-prostatic tumour nodules. Intra-prostatic tumour lesions will be treated with a radiotherapy boost. Radiotherapy boost: A dose escalated external beam radiotherapy boost to intraprostatic tumour nodules within the prostate gland; Follow Up Length: 60 month(s); Study Entry : Registration only Original interventions: 100 patients to be recruited and have MRI scans to diagnose intra-prostatic tumour nodules. 50% of patients expected to have lesions and so 50 patients to be treated with a radiotherapy boost Radiotherapy boost: A dose escalated external beam radiotherapy boost to intraprostatic tumour nodules within the prostate gland; Follow Up Length: 60 month(s); Study Entry : Registration only
Intervention type	Other
Primary outcome measure(s)	Late rectal toxicity; Timepoint(s): 12 months
Key secondary outcome measure(s)	1. Acute genitourinary (Gu) and gastrointestinal (GI) toxicity; Timepoint(s): 18 weeks 2. Biochemical Recurrence; Timepoint(s): 24 months 3. Late GU and GI toxicity; Timepoint(s): 12 months and 24 months 4. Quality of Life Scores; Timepoint(s): 24 months
Completion date	31/12/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	350
Total final enrolment	265
Key inclusion criteria	1. Age more than or equal to 18 years 2. Histologically confirmed adenocarcinoma of the prostate 3. National Collaborative Cancer Network+ (NCCN) risk groups intermediate or high risk localised prostate cancer 4. Normal blood count [haemoglobin (Hb) > 11g/dl, white blood cell (WBC) > 4000/mm³, platelets > 100,000/mm³] 5. World Health Organisation (WHO) performance status 0 or 1 6. Life expectancy of 10 years or more 7. Written informed consent 8. Patients must be prepared to attend follow-up 9. For template biopsy sub-study must be considered fit for general / spinal anaesthetic; Target Gender: Male ; Lower Age Limit 18 no age limit or unit specified
Key exclusion criteria	1. Prior radiotherapy to the prostate or pelvis 2. Bilateral hip replacement 3. Prior hormone therapy 4. Radical prostatectomy 5. Lymph Node Risk > 30% 6. National Collaborative Cancer Network+ (NCCN) Favourable Risk Group 7. Evidence of seminal vesicle invasion, nodal or metastatic disease 8. Any previous invasive cancer in the past 5 years, with the exception of non-melanoma skin cancer 9. Patients with medical contraindication to magnetic resonance imaging (MRI) scanning
Date of first enrolment	13/07/2011
Date of final enrolment	30/10/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Downs Road

Sutton
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		20/09/2022	29/09/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/09/2022: Total final enrolment added.
03/05/2017: The overall trial end date has been updated from 20/07/2014 to 31/12/2023 and the recruitment end date has been updated from 20/07/2014 to 30/10/2018. In addition, the target number of participants has been updated from 100 to 350 and the interventions section has been updated.
01/12/2016: No publications found in PubMed, verifying study status with principal investigator.